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  • AAMI EC11 : 1991

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    DIAGNOSTIC ELECTROCARDIOGRAPHIC DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-11-2011

    Language(s):  English

    Published date:  01-01-2007

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    1 Scope
    2 Normative references
    3 Requirements
    4 Test methods
    Annex A (informative) - Rationale for the development
                            and provisions of this standard
    Annex B (informative) - Cited references
    Annex C (informative) - Bibliography

    Abstract - (Show below) - (Hide below)

    Describes minimum safety and performance requirements for electrocardiographic (ECG) systems with direct writing devices which are intended for use, under the operating conditions specified in this standard, in the analysis of rhythm and of detailed morphology of complex cardiac complexes.

    General Product Information - (Show below) - (Hide below)

    Committee WG 04
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    A-A-53816 Base Document:1989 ELECTROCARDIOGRAPH, SINGLE CHANNEL
    CSA C22.2 No. 60601.2.51 : 2004 MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS
    EN 60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
    ISO 11073-91064:2009 Health informatics — Standard communication protocol — Part 91064: Computer-assisted electrocardiography
    IEEE DRAFT 1073.2 : SEP 95 MEDICAL DEVICES COMMUNICATIONS, APPLICATION PROFILES (MDAP) - FRAMEWORK AND OVERVIEW
    AAMI EC13 : 2002 CARDIAC MONITORS, HEART RATE METERS AND ALARMS
    BS EN 60601-2-51:2003 Medical electrical equipment. Particular requirements for safety Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
    I.S. EN 60601-2-51:2003 MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS
    IEC 60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

    Standards Referencing This Book - (Show below) - (Hide below)

    AAMI DF2 : 3ED 96 CARDIAC DEFIBRILLATOR DEVICES
    AAMI EC12 : 2000 DISPOSABLE ECG ELECTRODES
    AAMI ECGC : 1983 ECG CONNECTORS
    AAMI ES1 : 3ED 93 SAFE CURRENT LIMITS FOR ELECTROMEDICAL APPARATUS
    AAMI EC13 : 2002 CARDIAC MONITORS, HEART RATE METERS AND ALARMS
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